Clopidogrel Pharmacogenetics (PGX) Bench to Bedside

Completed · Not applicable

Conditions studied: Metabolism of Clopidogrel

In brief

Clopidogrel (also known as Plavix) is used commonly in patients to prevent heart attacks and conditions caused by blood clots. Although clopidogrel works in many individuals, some people do not respond as well to this drug. The variation in treatment response may be linked to genetics. This study will examine the effects of clopidogrel in a population in which sequencing for certain genes has been performed in order to determine the role that genes play in the response to various clopidogrel maintenance doses.

Key facts

Study ID

NCT01341600

Run by

University of Maryland, Baltimore

People needed

18

Starts

2010-07-01

Expected to finish

2011-05-01

Last updated by the study team

2024-01-30

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Amish men or women between 20 and 70 years of age who participated in PAPI

You may not qualify if…

• Severe hypertension (bp > 160/95 mm Hg)
• Co-existing malignancy
• Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 2 times normal
• Creatinine >2.0
• Hct < 32 or Hct > 50
• Thyroid Stimulating Hormone (TSH) < 0.40 or >5.50
• History of bleeding disorder or gastrointestinal bleeding
• History of unstable angina, myocardial infarction (MI), angioplasty, coronary artery bypass surgery
• History of atrial fibrillation, stroke or transient ischemic attacks or deep vein thrombosis
• Type 2 diabetes
• Thrombocytosis (platelet count > 500,000) or thrombocytopenia (platelet count < 150,000)
• Surgery within six months
• Clopidogrel allergy
• Pregnant women
• Currently breast feeding
• Omeprazole allergy
• Prospective participants taking medications that would affect the outcome(s) to be measured and who cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation, or who are taking vitamins and/or other supplements and who are unwilling to discontinue their use for at least 1 week prior to study

Where it is running

• Amish Research Clinic — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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